RESUMEN
Salacia oblonga holds potential as a natural method to mitigate the blood glucose response for people with diabetes by inhibiting the activity of intestinal alpha-glucosidases. As part of a safety evaluation of novel ingredients for use in blood glucose control, the toxicity of a S. oblonga root extract (SOE) was evaluated in a subchronic 90-day feeding study in rats. An in vivo-in vitro rat peripheral blood lymphocyte chromosomal aberrations assay was added at termination of the subchronic rat study to examine cultured lymphocytes for possible chromosomal aberration induction. This was conducted due to a previous weak; although reproducible, positive chromosomal aberrations response in cultured peripheral blood human lymphocytes after acute in vitro treatment with SOE. The present study results indicate that SOE was negative for the induction of chromosomal aberrations in cultured rat peripheral blood lymphocytes after 90 consecutive days of treatment with SOE. The no observable adverse effect level (NOAEL) was determined to be 2,500 mg/kg/day following daily subchronic oral gavage administrations to rats.
Asunto(s)
Aberraciones Cromosómicas/efectos de los fármacos , Mutágenos/toxicidad , Salacia/química , Salacia/toxicidad , Animales , Recuento de Células Sanguíneas , Peso Corporal/efectos de los fármacos , Colorantes , Ingestión de Alimentos/efectos de los fármacos , Etanol , Oftalmopatías/inducido químicamente , Oftalmopatías/patología , Femenino , Hígado/efectos de los fármacos , Linfocitos/efectos de los fármacos , Linfocitos/ultraestructura , Masculino , Nivel sin Efectos Adversos Observados , Oftalmoscopía , Tamaño de los Órganos/efectos de los fármacos , Extractos Vegetales/toxicidad , Ratas , Caracteres Sexuales , Solventes , Análisis de Supervivencia , AguaRESUMEN
Salacia oblonga has been used for thousands of years in Ayurvedic medicine for the oral treatment of diabetes. The root extract has been shown to inhibit the activity of intestinal alpha-glucosidases, therefore S. oblonga holds potential as a natural method to mitigate the blood glucose response for people with diabetes. As part of a safety evaluation of novel ingredients for use in blood glucose control, the potential genotoxicity of a S. oblonga root extract (SOE) was evaluated using the standard battery of tests (reverse mutation assay; chromosomal aberrations assay; mouse micronucleus assay) recommended by US Food and Drug Administration (FDA) for food ingredients. SOE was determined not to be genotoxic under the conditions of the reverse mutation assay and mouse micronucleus assay, and weakly positive for the chromosomal aberrations assay. A reproducible, although weak, positive chromosomal aberrations response in human lymphocytes is of concern and further toxicity research is recommended. Use of SOE is presently expected to be safe, as anticipated intake is small compared to the doses administered in the genotoxicity assays and may, after further toxicity research, may prove be a useful ingredient in foodstuffs.
Asunto(s)
Inhibidores Enzimáticos/toxicidad , Pruebas de Mutagenicidad , Mutágenos/toxicidad , Extractos Vegetales/toxicidad , Salacia/química , Animales , Aberraciones Cromosómicas/efectos de los fármacos , Relación Dosis-Respuesta a Droga , Escherichia coli/efectos de los fármacos , Escherichia coli/genética , Escherichia coli/metabolismo , Inhibidores de Glicósido Hidrolasas , Humanos , Masculino , Medicina Ayurvédica , Ratones , Ratones Endogámicos , Micronúcleos con Defecto Cromosómico/inducido químicamente , Mutágenos/clasificación , Mutágenos/metabolismo , Extractos Vegetales/clasificación , Extractos Vegetales/metabolismo , Plantas Medicinales , Ratas , Ratas Sprague-Dawley , Proteína Ribosómica S9 , Proteínas Ribosómicas/efectos de los fármacos , Proteínas Ribosómicas/metabolismo , Salmonella typhimurium/efectos de los fármacos , Salmonella typhimurium/genética , Salmonella typhimurium/metabolismoRESUMEN
Fenugreek seeds have been used in traditional medicines as a remedy for diabetes. Rich in protein, fenugreek seeds contain the unique major free amino acid 4-hydroxyisoleucine (4-OH-Ile), which has been characterized as one of the active ingredients for blood glucose control. Current use of fenugreek in foodstuff has been limited to its role as a flavoring agent, and not as an ingredient to help mitigate the blood glucose response for people with diabetes. As part of a safety evaluation of novel ingredients for use in blood glucose control, the potential genotoxicity of a fenugreek seed extract (THL), containing a minimum of 40% 4-OH-ILE, was evaluated using the standard battery of tests (reverse mutation assay; mouse lymphoma forward mutation assay; mouse micronucleus assay) recommended by US Food and Drug Administration (FDA) for food ingredients. THL was determined not to be genotoxic under the conditions of the tested genetic toxicity battery. The negative assay results provide support that addition of THL to foodstuffs formulated for people with diabetes is expected to be safe. A wide safety margin is established, as anticipated doses are small compared to the doses administered in the assays.